Application Nr Approved Date Route Status External Links
ANDA211908 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ziprasidone Mesylate For Injection Intramuscular Is Indicated For Acute Agitation In Schizophrenic Patients. When Deciding Among The Alternative Treatments Available For The Condition Needing Treatment, The Prescriber Should Consider The Finding Of Ziprasidone’s Greater Capacity To Prolong The Qt/qtc Interval Compared To Several Other Antipsychotic Drugs [See Warnings And Precautions (5.3) ]. Prolongation Of The Qtc Interval Is Associated In Some Other Drugs With The Ability To Cause Torsade De Pointes-Type Arrhythmia, A Potentially Fatal Polymorphic Ventricular Tachycardia, And Sudden Death. In Many Cases This Would Lead To The Conclusion That Other Drugs Should Be Tried First. Whether Ziprasidone Will Cause Torsade De Pointes Or Increase The Rate Of Sudden Death Is Not Yet Known [See Warnings And Precautions (5.3) ] Acute Treatment Of Agitation In Schizophrenia Ziprasidone Mesylate For Injection Intramuscular Is Indicated For The Treatment Of Acute Agitation In Schizophrenic Adult Patients For Whom Treatment With Ziprasidone Is Appropriate And Who Need Intramuscular Antipsychotic Medication For Rapid Control Of Agitation. Since There Is No Experience Regarding The Safety Of Administering Ziprasidone Intramuscular To Schizophrenic Patients Already Taking Oral Ziprasidone, The Practice Of Co-Administration Is Not Recommended. Ziprasidone Mesylate For Injection Is An Atypical Antipsychotic. In Choosing Among Treatments, Prescribers Should Be Aware Of The Capacity Of Ziprasidone Mesylate For Injection To Prolong The Qt Interval And May Consider The Use Of Other Drugs First ( 5.3 ) Ziprasidone Mesylate For Injection As An Intramuscular Injection Is Indicated For The: • Acute Treatment Of Agitation In Schizophrenic Patients. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ziprasidone Mesylate ZIPRASIDONE MESYLATE ZINC538550

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